FDA product code · Orthopedic
MAIFastener, Fixation, Biodegradable, Soft Tissue
Product code MAI covers Fastener, Fixation, Biodegradable, Soft Tissue, a Class II device regulated under 21 CFR 888.3030. FDA has cleared 220 devices in this code, 6 of them in the last 12 months. Median review time across the 220 most recent decisions is 85 days. openFDA lists 96 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3030
- Review panel
- Orthopedic
- Clearances
- 220
What is happening in MAI right now?
MAI (Fastener, Fixation, Biodegradable, Soft Tissue) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1166-2026, Z-1167-2026, Z-1168-2026, Z-1169-2026, Z-1170-2026). 1 first-time filer in the last 12 months, Biocomposites, Ltd (K251680). The code is crowded, scoring 67 of 100 — 59 companies hold a clearance here and 6 arrived in the last 12 months (MAI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1166-2026, Z-1167-2026, Z-1168-2026, Z-1169-2026, Z-1170-2026 |
| New entrant | Worth knowing | K251680 |
| Crowding | Context | MAI:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MAI?
FDA has cleared 220 devices under product code MAI since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | |
| K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | |
| K254055 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | |
| K252022 | OSSIOfiber® Interference Screw | OSSIO , Ltd. | |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO , Ltd. | |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | Stryker Endoscopy | |
| K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. |
How long does FDA review take for MAI?
The median FDA review time for MAI is 85 days, measured across the 220 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MAI?
openFDA lists 96 recall records against product code MAI. A recall record covers one firm's corrective action and may span many device lots.
Z-1166-2026Open, ClassifiedAju Pharm Co., Ltd.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1167-2026Open, ClassifiedAju Pharm Co., Ltd.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1168-2026Open, ClassifiedAju Pharm Co., Ltd.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1169-2026Open, ClassifiedAju Pharm Co., Ltd.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Z-1170-2026Open, ClassifiedAju Pharm Co., Ltd.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Showing the 5 most recently initiated of 96. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MAI?
MAUDE holds 6,269 adverse-event reports naming product code MAI, 1,639 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MAI unusual?
2 months sit above MAI's own expected range: 1 September 2025, 1 February 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 88 | Insufficient history | No expected range — too little history | |
| 74 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 129 | Insufficient history | No expected range — too little history | |
| 133 | Insufficient history | No expected range — too little history | |
| 133 | Insufficient history | No expected range — too little history | |
| 171 | Insufficient history | No expected range — too little history | |
| 121 | Insufficient history | No expected range — too little history | |
| 190 | Insufficient history | No expected range — too little history | |
| 141 | Insufficient history | No expected range — too little history | |
| 172 | Insufficient history | No expected range — too little history | |
| 237 | Insufficient history | No expected range — too little history | |
| 266 | Insufficient history | No expected range — too little history | |
| 235 | Insufficient history | No expected range — too little history | |
| 197 | Insufficient history | No expected range — too little history | |
| 145 | Insufficient history | No expected range — too little history | |
| 177 | Insufficient history | No expected range — too little history | |
| 185 | Insufficient history | No expected range — too little history | |
| 170 | Insufficient history | No expected range — too little history | |
| 186 | Insufficient history | No expected range — too little history | |
| 157 | 84–250 | Within expected (84–250) | |
| 123 | 69–216 | Within expected (69–216) | |
| 115 | 71–235 | Within expected (71–235) | |
| 184 | 56–240 | Within expected (56–240) | |
| 170 | 72–226 | Within expected (72–226) | |
| 166 | 97–225 | Within expected (97–225) | |
| 188 | 193–315 | Below expected (193–315) | |
| 168 | 126–227 | Within expected (126–227) | |
| 236 | 133–233 | Above expected (133–233) | |
| 247 | 142–254 | Within expected (142–254) | |
| 139 | 133–250 | Within expected (133–250) | |
| 228 | 126–264 | Within expected (126–264) | |
| 170 | 153–319 | Within expected (153–319) | |
| 313 | 108–258 | Above expected (108–258) | |
| 197 | 130–356 | Within expected (130–356) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MAI.
Who has entered MAI in the last year?
One company filed in MAI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Biocomposites, Ltd. | K251680 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in MAI?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MAI?
Across the 220 most recent decisions, these applicants filed most often in MAI.
| Applicant | Recent clearances |
|---|---|
| Arthrex, Inc. | 45 |
| Depuy Mitek, A Johnson & Johnson Company | 18 |
| Linvatec Corp. | 11 |
| Smith & Nephew, Inc. | 10 |
| Medos International SARL | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in MAI file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Depuy Mitek, A Johnson and Johnson Company | 20 | 2 |
| Linvatec Corp. dba ConMed Linvatec | 12 | 2 |
| Smith & Nephew, Inc. | 12 | 2 |
| Bionx Implants, Inc. | 11 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MAI
Get an email the morning anything changes in MAI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.